Increased Risk of Clotting



Ortho McNeil, a subsidiary of Johnson & Johnson and the manufacturer of the Ortho Evra birth control patch, originally claimed that the risk of developing blood clots as a result of using the Ortho Evra patch is no different from the blood clotting risk posed by the use of oral contraceptives. However, according to published reports, data obtained from the FDA pursuant to a Freedom of Information request suggest that the risk of clotting from the use of the Orho Evra patch is three times greater than the clotting risk posed by the use of oral contraceptives. Moreover, the data also suggest that the risk of dying from the use of the Ortho Evra patch is also three times greater than the risk of dying from the use of oral contraceptives. These observations are based upon data that was collected by Ortho McNeil and reported to the FDA prior to the FDA's approval of the Ortho Evra patch.

According to the Associated Press, the data indicates that "[I]f you are a woman taking the pill who doesn't smoke and is under 35, the chance that you are going to have a blood clot that doesn't kill you is between 1 and 3 in 10,000. Your risk of dying from a blood clot while using the pill is 1 in 200,000. By contrast, with the patch, the rate of nonfatal blood clots was about 12 out of 10,000 users during the clinical trials while the rate of deaths appears to be 3 out of 200,000."

On November 10, 2005, the FDA announced a revision to the labeling for the Ortho Evra birth control patch. The new labeling provides a warning that women who use the Ortho Evra birth control patch may be exposed to approximately 60% more estrogen than women who use oral contraceptives. Exposure to higher levels of estrogen carries an increased risk of developing blood clots that can lead to serious health consequences such as heart attack, stroke and pulmonary embolism.